Symptomatic Irreversible PulpitisBCvsCaOHNCT07410780
Postoperative Pain After Root Canal Obturation Using Bioceramic and Calcium Hydroxide Sealers
A study testing CeraSeal Bioceramic Sealer and Sealapex Calcium Hydroxide Sealer in people with Symptomatic Irreversible Pulpitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This study is designed to find out how different root canal sealers affect pain after root canal treatment. We are comparing two types of dental sealers: bioceramic sealer and calcium hydroxide sealer. Participants who need root canal treatment will receive one of these sealers as part of their standard dental care. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- CeraSeal Bioceramic Sealer and Sealapex Calcium Hydroxide Sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-40 years
- Single-rooted permanent teeth
- Teeth diagnosed with symptomatic irreversible pulpitis
- Normal periapical condition on radiographic examination or periodontal ligament (PDL) space widening
- Restorable teeth
Who cannot join
- Patients with systemic conditions that could alter the course of treatment
- Teeth with immature root development
- Teeth with necrotic pulp
- Teeth exhibiting root resorption
- Teeth with calcified root canals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Beenish Qureshi, BDS, FCPS contact
Pakistan1 site, 1 recruiting
- Recruiting
Department of Operative Dentistry, HITEC-IMS Dental College
Rawalpindi, Punjab Province
Monal Fatima, BDS, 03004410676, manalfatima1100@gmail.com
Beenish Qureshi, BDS, FCPS, +92 333 4368332
About this study
Official title: Assessment of Postoperative Pain in Patients Obturated With Bioceramic and Calcium Hydroxide Sealers: A Randomized Clinical Trial
This study is designed to find out how different root canal sealers affect pain after root canal treatment. We are comparing two types of dental sealers: bioceramic sealer and calcium hydroxide sealer.
Participants who need root canal treatment will receive one of these sealers as part of their standard dental care. After the procedure, they will be asked to report any pain they experience for a few days.
The information from this study will help dentists choose sealers that may reduce post-treatment pain and improve patient comfort after root canal therapy.
Read the detailed description
This randomized controlled clinical trial is designed to evaluate postoperative pain following root canal obturation using two different endodontic sealers: a bioceramic (calcium silicate-based) sealer and a calcium hydroxide-based sealer. Postoperative pain is a common complication of root canal therapy and may influence patient satisfaction as well as perceived treatment success. The physical and chemical properties of root canal sealers may contribute to postoperative discomfort through their interaction with periapical tissues.
The study will be conducted at the Department of Operative Dentistry, HITEC-IMS Dental College over a period of six months to 1 year following institutional approval. A total sample size of 50 participants will be enrolled and randomly allocated into two parallel groups using a lottery method, with 25 participants assigned to each group. A single-blind design will be maintained, in which participants will be unaware of the sealer used.
All clinical procedures will be performed in a single visit by the same operator to minimize procedural variability. Following diagnosis and confirmation of pulp vitality, standard endodontic treatment will be carried out under local anesthesia and rubber dam isolation. Canal preparation will be performed using hand and nickel-titanium rotary instruments. Irrigation will be carried out using sodium hypochlorite and EDTA solutions, followed by saline as the final rinse. Canals will be dried using sterile paper points.
Obturation will be performed using a single-cone technique with a matching-taper gutta-percha cone coated with the assigned sealer. Participants in the experimental groups will receive either a bioceramic sealer or a calcium hydroxide-based sealer. Access cavities will be restored with glass ionomer cement, and occlusal reduction will be performed to minimize postoperative discomfort due to occlusal trauma. No postoperative medications will be prescribed.
Postoperative pain will be evaluated using a Visual Analog Scale (VAS) at predefined time intervals following obturation. Analgesic intake, if any, will also be recorded to support accurate interpretation of pain outcomes.
Collected data will be entered into a spreadsheet and analyzed using statistical software. Comparative analysis of postoperative pain scores between the two groups at different time intervals will be performed using appropriate statistical tests.
Participant confidentiality will be maintained throughout the study. All collected data will be anonymized and used exclusively for research purposes.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- CeraSeal Bioceramic Sealer, Sealapex Calcium Hydroxide Sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraSeal Bioceramic SealerProcedure or surgery
Participants will receive root canal obturation using CeraSeal Bioceramic Sealer. The sealer will be applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. The cavity will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using a Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours.
Sealapex Calcium Hydroxide SealerProcedure or surgery
Participants will receive root canal obturation using Sealapex Calcium Hydroxide Sealer applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. Cavities will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using the VAS at 12, 24, 48, and 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic Sealer Group | Experimental | Participants in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer (CeraSeal) following standard endodontic procedures. After proper anesthesia and rubber dam isolation, the canals will be prepared, irrigated, and dried. A single-cone obturation technique will be used to place the sealer and gutta-percha. The cavities will be sealed with glass ionomer cement, and patients will record postoperative pain using the Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours. Receives: Procedure: CeraSeal Bioceramic Sealer |
| Calcium Hydroxide Sealer | Experimental | Participants in this group will receive root canal obturation using calcium hydroxide-based sealer (Sealapex) following the same standard endodontic procedures as Arm 1. Postoperative pain will be measured using the VAS at 12, 24, 48, and 72 hours. Receives: Procedure: Sealapex Calcium Hydroxide Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Following Root Canal Obturation
Postoperative pain will be measured at 12, 24, 48, and 72 hours following root canal obturation. Pain intensity will be assessed using a Visual Analog Scale (VAS), where 0 represents "no pain," 1-3 indicates mild pain, 4-6 moderate pain, and 7-10 severe pain. Patients will record their pain scores at each time point, and any use of analgesics will also be documented to ensure accurate assessment.
Measured: 12, 24, 48, and 72 hours after root canal obturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: Group A, receiving bioceramic sealer, or Group B, receiving calcium hydroxide sealer. Each participant will remain in their assigned group for the duration of the study, and postoperative pain will be measured at 12, 24, 48, and 72 hours.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, monal fatima, HITEC-Institute of Medical Sciences
- Investigators
- Monal Fatima, Principal investigator, HITEC-IMS, Department of Operative Dentistry, Taxila, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410780
- Sponsor's protocol ID
- HITEC-IMS-ENDO-RCT-2025
- Acronym
- BCvsCaOH
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. All data collected will be kept strictly confidential, anonymized, and used only by the research team for analysis and reporting of study results. No identifiable patient information will be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain in Patients Obturated With Bioceramic and Calcium Hydroxide Sealers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07410780
- Acronym / sponsor ID
- BCvsCaOH / HITEC-IMS-ENDO-RCT-2025
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to find out how different root canal sealers affect pain after root canal treatment. We are comparing two types of dental sealers: bioceramic sealer and calcium hydroxide sealer.
Participants who need root canal treatment will receive one of these sealers as part of their standard dental care. After the procedure, they will be asked to report any pain they experience for a few days.
The information from this study will help dentists choose sealers that may reduce post-treatment pain and improve patient comfort after root canal therapy.
Detailed description
This randomized controlled clinical trial is designed to evaluate postoperative pain following root canal obturation using two different endodontic sealers: a bioceramic (calcium silicate-based) sealer and a calcium hydroxide-based sealer. Postoperative pain is a common complication of root canal therapy and may influence patient satisfaction as well as perceived treatment success. The physical and chemical properties of root canal sealers may contribute to postoperative discomfort through their interaction with periapical tissues.
The study will be conducted at the Department of Operative Dentistry, HITEC-IMS Dental College over a period of six months to 1 year following institutional approval. A total sample size of 50 participants will be enrolled and randomly allocated into two parallel groups using a lottery method, with 25 participants assigned to each group. A single-blind design will be maintained, in which participants will be unaware of the sealer used.
All clinical procedures will be performed in a single visit by the same operator to minimize procedural variability. Following diagnosis and confirmation of pulp vitality, standard endodontic treatment will be carried out under local anesthesia and rubber dam isolation. Canal preparation will be performed using hand and nickel-titanium rotary instruments. Irrigation will be carried out using sodium hypochlorite and EDTA solutions, followed by saline as the final rinse. Canals will be dried using sterile paper points.
Obturation will be performed using a single-cone technique with a matching-taper gutta-percha cone coated with the assigned sealer. Participants in the experimental groups will receive either a bioceramic sealer or a calcium hydroxide-based sealer. Access cavities will be restored with glass ionomer cement, and occlusal reduction will be performed to minimize postoperative discomfort due to occlusal trauma. No postoperative medications will be prescribed.
Postoperative pain will be evaluated using a Visual Analog Scale (VAS) at predefined time intervals following obturation. Analgesic intake, if any, will also be recorded to support accurate interpretation of pain outcomes.
Collected data will be entered into a spreadsheet and analyzed using statistical software. Comparative analysis of postoperative pain scores between the two groups at different time intervals will be performed using appropriate statistical tests.
Participant confidentiality will be maintained throughout the study. All collected data will be anonymized and used exclusively for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: Group A, receiving bioceramic sealer, or Group B, receiving calcium hydroxide sealer. Each participant will remain in their assigned group for the duration of the study, and postoperative pain will be measured at 12, 24, 48, and 72 hours.
| Arm | Type | Receives |
|---|---|---|
| Bioceramic Sealer Group | Experimental | Procedure: CeraSeal Bioceramic SealerParticipants in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer (CeraSeal) following standard endodontic procedures. After proper anesthesia and rubber dam isolation, the canals will be prepared, irrigated, and dried. A single-cone obturation technique will be used to place the sealer and gutta-percha. The cavities will be sealed with glass ionomer cement, and patients will record postoperative pain using the Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours. |
| Calcium Hydroxide Sealer | Experimental | Procedure: Sealapex Calcium Hydroxide SealerParticipants in this group will receive root canal obturation using calcium hydroxide-based sealer (Sealapex) following the same standard endodontic procedures as Arm 1. Postoperative pain will be measured using the VAS at 12, 24, 48, and 72 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18-40 years
- Single-rooted permanent teeth
- Teeth diagnosed with symptomatic irreversible pulpitis
- Normal periapical condition on radiographic examination or periodontal ligament (PDL) space widening
- Restorable teeth
Key exclusion criteria (5 listed)
- Patients with systemic conditions that could alter the course of treatment
- Teeth with immature root development
- Teeth with necrotic pulp
- Teeth exhibiting root resorption
- Teeth with calcified root canals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraSeal Bioceramic SealerParticipants will receive root canal obturation using CeraSeal Bioceramic Sealer. The sealer will be applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. The cavity will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using a Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours. | Procedure or surgery | Bioceramic Sealer Group |
| Sealapex Calcium Hydroxide SealerParticipants will receive root canal obturation using Sealapex Calcium Hydroxide Sealer applied with a matching-taper gutta-percha cone using the single-cone technique after standard canal preparation and irrigation. Cavities will be sealed with glass ionomer cement. Postoperative pain will be recorded by participants using the VAS at 12, 24, 48, and 72 hours. | Procedure or surgery | Calcium Hydroxide Sealer |
Primary outcome
Postoperative Pain Following Root Canal Obturation
Time frame: 12, 24, 48, and 72 hours after root canal obturation
Postoperative pain will be measured at 12, 24, 48, and 72 hours following root canal obturation. Pain intensity will be assessed using a Visual Analog Scale (VAS), where 0 represents "no pain," 1-3 indicates mild pain, 4-6 moderate pain, and 7-10 severe pain. Patients will record their pain scores at each time point, and any use of analgesics will also be documented to ensure accurate assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- The Effects of Calcium Silicate- and Calcium Hydroxide-based Root Canal Sealers on Postoperative Pain: A Randomized Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. All data collected will be kept strictly confidential, anonymized, and used only by the research team for analysis and reporting of study results. No identifiable patient information will be made publicly available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beenish Qureshi, BDS, FCPS contact
Monal Fatima principal investigator
HITEC-IMS, Department of Operative Dentistry, Taxila, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraSeal Bioceramic Sealer and Sealapex Calcium Hydroxide Sealer in people with Symptomatic Irreversible Pulpitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monal Fatima, BDS (03004410676, manalfatima1100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Following Root Canal Obturation (time frame: 12, 24, 48, and 72 hours after root canal obturation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.